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Fractional CO2 Laser Assisted Photodynamic Therapy

Primary Purpose

Actinic Keratosis, Basal Cell Carcinoma

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Conventional photodynamic therapy

Fractional CO2 laser assisted PDT

About this trial

This is an interventional treatment trial for Actinic Keratosis focused on measuring Moderate to severe actinic keratoses, Difficult to treat nodular basal cell carcinomas

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18 or older
Skin type I-III
Fertile women using secure birth control
Moderate to severe actinic keratoses in the face or on the hands,
Difficult to treat nodular basal cell carcinomas in the face

Exclusion Criteria:

Pregnancy or breast feeding patients
Patients with porphyria
Patients with Gorlins syndrome
Patients with a tendency to produce hypertrophic scars or keloids
Patients with known allergy to Metvix
Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic, dementia, mentally ill etc.)
Patients with pigmented or morphea basal cell carcinomas
Know herpes simplex virus infection in treatment areas

Sites / Locations

Department of Dermatology, Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

AK split-face treatment

Fractional laser assisted PDT for BCC

Konventional PDT for BCC

Arm Description

Split-face treatment of two symmetrical areas with moderate to severe actinic keratoses. One area is treated with conventional PDT the other with fractional laser assisted PDT.

Difficult to treat nodular basal cell carcinomas in the face is pretreated with fractional CO2 laser followed by methyl-aminolevulinate PDT.

Difficult to treat nodular basal cell carcinomas in the face is treated with methyl-aminolevulinate PDT.

Outcomes

Primary Outcome Measures

Treatment response

Clinical evaluation by a blinded physician.

Reoccurrence

Clinical evaluation by a blinded physician

Treatment response

Blinded histological examination from patients with basal cell carcinomas

Secondary Outcome Measures

Pain

Patient score (VAS 0-10)

Adverse effects

scaring, hyper- and hypopigmentation

Fluorescence

Methyl-amonolevulinate uptake

Cosmetic result

4-point scale

Full Information

NCT ID

NCT01260987

First Posted

December 14, 2010

Last Updated

July 29, 2015

Sponsor

Bispebjerg Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01260987

Brief Title

Fractional CO2 Laser Assisted Photodynamic Therapy

Official Title

Conventional Versus Fractional CO2 Laser Assisted Photodynamic Therapy for Basal Call Carcinomas and Actinic Keratoses

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bispebjerg Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Nodular Basal Cell Carcinomas: Compare the efficacy and safety of conventional versus fractional laser assisted PDT for difficult to treat nodular cell carcinomas in the face. Actinic keratosis: Compare the efficacy and safety of conventional versus fractional laser assisted PDT for moderate to severe actinic keratoses located in the face and on the hands.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Actinic Keratosis, Basal Cell Carcinoma

Keywords

Moderate to severe actinic keratoses, Difficult to treat nodular basal cell carcinomas

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

47 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AK split-face treatment

Arm Type

Active Comparator

Arm Description

Split-face treatment of two symmetrical areas with moderate to severe actinic keratoses. One area is treated with conventional PDT the other with fractional laser assisted PDT.

Arm Title

Fractional laser assisted PDT for BCC

Arm Type

Active Comparator

Arm Description

Difficult to treat nodular basal cell carcinomas in the face is pretreated with fractional CO2 laser followed by methyl-aminolevulinate PDT.

Arm Title

Konventional PDT for BCC

Arm Type

Active Comparator

Arm Description

Difficult to treat nodular basal cell carcinomas in the face is treated with methyl-aminolevulinate PDT.

Intervention Type

Drug

Intervention Name(s)

Conventional photodynamic therapy

Intervention Description

Photodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2)

Intervention Type

Drug

Intervention Name(s)

Fractional CO2 laser assisted PDT

Intervention Description

Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT

Primary Outcome Measure Information:

Title

Treatment response

Description

Clinical evaluation by a blinded physician.

Time Frame

3 months

Title

Reoccurrence

Description

Clinical evaluation by a blinded physician

Time Frame

12 months

Title

Treatment response

Description

Blinded histological examination from patients with basal cell carcinomas

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Pain

Description

Patient score (VAS 0-10)

Time Frame

during laser and PDT

Title

Adverse effects

Description

scaring, hyper- and hypopigmentation

Time Frame

12 months

Title

Fluorescence

Description

Methyl-amonolevulinate uptake

Time Frame

3 hours

Title

Cosmetic result

Description

4-point scale

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18 or older Skin type I-III Fertile women using secure birth control Moderate to severe actinic keratoses in the face or on the hands, Difficult to treat nodular basal cell carcinomas in the face Exclusion Criteria: Pregnancy or breast feeding patients Patients with porphyria Patients with Gorlins syndrome Patients with a tendency to produce hypertrophic scars or keloids Patients with known allergy to Metvix Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic, dementia, mentally ill etc.) Patients with pigmented or morphea basal cell carcinomas Know herpes simplex virus infection in treatment areas

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Merete Hædersdal, PhD,DrMedSci

Organizational Affiliation

Bispebjerg Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Dermatology, Bispebjerg Hospital

City

Copenhagen

ZIP/Postal Code

DK-2400

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

Fractional CO2 Laser Assisted Photodynamic Therapy

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